NL-OMON41706
Completed
Not Applicable
Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett*s Epithelium - Efficacy EBCA focal
C2Therapeutics0 sites40 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- esophageal cancer
- Sponsor
- C2Therapeutics
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a) Patients with known Barrett\*s esophagus, scheduled for treatment with focal radiofrequency ablation (HALO\-90\) \[i.e. in patients with islands or residual Barrett\*s after circumferential radiofrequency ablation (HALO\-360\) or in patients for whom circumferential radiofrequency ablation is not feasible], during which the cryoablation may be performed.
- •b) Patient is 18 to 80 years of age at the time of consent (inclusive).
- •c) Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution\*s reviewing IRB/EC.
- •d) Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
- •e) Patient is deemed operable per standard institutional criteria.
- •f) Each patient will have one (group of) island of BE \*1 cm2 where the Cryoballoon Focal Ablation System can be successfully positioned within the BE lesion.
- •g) BE lesion within the treatment zone should be flat.
Exclusion Criteria
- •a) Esophageal stenosis preventing advancement of a therapeutic endoscope and/or within 4 cm of treatment zone.
- •b) Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post treatment instructions or follow\-up guidelines.
- •c) Patient refuses or is unable to provide written informed consent.
- •d) Patients that are pregnant.
- •e) Patient with endoscopically active inflammation in the treatment zone.
- •f) Endoscopically visible abnormalities such as masses or nodules requiring endoscopic resection.
Outcomes
Primary Outcomes
Not specified
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